A Nutritional Intervention in Police Officers

NCT02651480 | Suspended DMC

• 1 other identifier: PCRM MPD
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

The proposed study seeks to test the effect of a plant-based dietary intervention on cardiovascular risk factors in police officers.

Conditions

Overweight; Blood Pressure; Diabetes Mellitus, Type 2

Keywords

Diet, Vegetarian; Diet, Fat-Restricted; Quality of Life; Glycemic Index

Outcome Measures

Primary Outcomes (3)

• Body Weight

  body weight will be measured to the nearest 0.1 kg, using a digital scale.

  Changes in body weight from Baseline at 14 weeks

• Plasma lipid concentrations

  will be measured using the Olympus Cholesterol Reagent on Olympus Chemistry Analyzers to assess changes in plasma lipid concentrations.

  Changes in plasma lipid concentrations from Baseline at 14 weeks

• Blood pressure

  Blood pressure will be measured at each assessment

  Changes in blood pressure from Baseline at 14 weeks

Secondary Outcomes (1)

• Quality of Life and Mood

  Change in quality of life from Baseline at 4 months

Study Arms (2)

Vegan Group

EXPERIMENTAL

Participants in the intervention group will follow a low-fat, plant-based diet for 14 weeks, and will attend nutrition classes in the form of a weekly support group.

Dietary Supplement: Plant-based diet

Control Group

ACTIVE COMPARATOR

The control group will follow an unrestricted diet with no instruction.

Dietary Supplement: Control Group

Interventions

Plant-based diet DIETARY_SUPPLEMENT

Weekly instructions will be given to the participants in the intervention group about following vegan diet.

Also known as: Vegan Group

Vegan Group

Control Group DIETARY_SUPPLEMENT

Unrestricted diet with no instruction.

Also known as: Control

Control Group

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Men and women at least 18 years
• Body mass index ≥ 25 kg/m2 and/or a diagnosis of type 2 diabetes mellitus, as defined by a fasting plasma glucose concentration ≥ 126 mg/dl on two occasions or a prior physician's diagnosis of type 2 diabetes
• Currently an employee of the Metropolitan Police Department of the District of Columbia
• Ability and willingness to participate in all components of the study
• A willingness to be randomly assigned to either study group

You may not qualify if:

• Alcohol consumption of more than 2 drinks per day or the equivalent, episodic increased drinking (e.g., more than 2 drinks per day on weekends), or a history of alcohol abuse or dependency followed by any current use
• Pregnancy
• Unstable medical or psychiatric illness
• Likely to be disruptive in group sessions (as determined by research staff)
• Already following a low-fat, vegan diet
• Lack of English fluency
• Inability or unwillingness to participate in all components of the study

Sponsors & Collaborators

• Physicians Committee for Responsible Medicine: lead
• Metropolitan Police Department of Washington, D.C.: collaborator

Study Sites (1)

Physicians Committee for Responsible Medicine

Washington D.C., District of Columbia, 20016, United States

Location

MeSH Terms

Conditions

Overweight; Diabetes Mellitus, Type 2

Interventions

Diet, Plant-Based; Control Groups

Condition Hierarchy (Ancestors)

Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Diet Therapy; Nutrition Therapy; Therapeutics; Diet; Nutritional Physiological Phenomena; Diet, Food, and Nutrition; Physiological Phenomena; Epidemiologic Research Design; Epidemiologic Methods; Investigative Techniques; Research Design; Methods

Study Officials

• Neal D Barnard, M.D.

  President

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: CARE PROVIDER
• Purpose: SUPPORTIVE CARE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 7, 2016
• First Posted: January 11, 2016
• Study Start: February 1, 2016
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: June 27, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)